MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TC3 RP TIBIAL INSERT S5,25.0; SIGMA REVISION IMPLANT : KNEE TIBIAL INSERT

Model Number	96-2367
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Low Blood Pressure/ Hypotension (1914); Pain (1994); Sepsis (2067); Discomfort (2330); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Clinical notification received for revision of right total knee to address infection date of implantation: (b)(6) 2018, date of revision: (b)(6) 2020, (right knee).Treatment: tibial insert revised.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot : product/lot information is not available.

• Brand Name: TC3 RP TIBIAL INSERT S5,25.0
• Common Device Name: SIGMA REVISION IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10993544
• Report Number: 1818910-2020-26820
• Device Sequence Number: 702224
• Product Code: NJL
• UDI-Device Identifier: 10603295242567
• UDI-Public: 10603295242567
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 96-2367
• Device Catalogue Number: 962367
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/30/2020
• Supplement Date Received by Manufacturer: 01/08/2021
• Initial Report FDA Received Date: 12/11/2020
• Supplement Report FDA Received Date: 01/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DEPUY1 GENTAMICIN CEMENT 40G; DEPUY1 GENTAMICIN CEMENT 40G; DEPUY1 GENTAMICIN CEMENT 40G; DEPUY1 GENTAMICIN CEMENT 40G; MBT REVISION CEM TIB TRAY SZ 4; MBT TRAY SLEEVE POR M/L 61MM; PFC SIGMA FEM POST AUG SZ5 8MM; PFC SIGMA FEM POST AUG SZ5 8MM; PFC*SIGMA DIS AUG 4MM,SZ5,RGHT; PFC*SIGMA DIS AUG 4MM,SZ5,RGHT; PFC*SIGMA TC3 FEM RT SZ5; PFC*SIGMA/OV/DOME PAT 3PEG,38; SIG FEM ADAP +2/-2 OFFSET BOLT; SIGMA FEM ADAPTER 5 DEGREE; TC3 RP TIBIAL INSERT S5,25.0; UNIVERSAL FEM SLV DIS POR 46MM; UNIVERSAL STEM 115X14MM FLUTED; UNIVERSAL STEM 75X20MM FLUTED; DEPUY1 GENTAMICIN CEMENT 40G; DEPUY1 GENTAMICIN CEMENT 40G; DEPUY1 GENTAMICIN CEMENT 40G; DEPUY1 GENTAMICIN CEMENT 40G; MBT REVISION CEM TIB TRAY SZ 4; MBT TRAY SLEEVE POR M/L 61MM; PFC SIGMA FEM POST AUG SZ5 8MM; PFC SIGMA FEM POST AUG SZ5 8MM; PFC*SIGMA DIS AUG 4MM,SZ5,RGHT; PFC*SIGMA DIS AUG 4MM,SZ5,RGHT; PFC*SIGMA TC3 FEM RT SZ5; PFC*SIGMA/OV/DOME PAT 3PEG,38; SIG FEM ADAP +2/-2 OFFSET BOLT; SIGMA FEM ADAPTER 5 DEGREE; TC3 RP TIBIAL INSERT S5,25.0; UNIVERSAL FEM SLV DIS POR 46MM; UNIVERSAL STEM 115X14MM FLUTED; UNIVERSAL STEM 75X20MM FLUTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Weight: 109